Tobacco Products

Regulating Tobacco - An FDA Perspective

On June 22, 2009, President Obama signed a historic bill to protect the public health by giving the Food and Drug Administration (FDA) the authority to regulate tobacco products. The new law, the Family Smoking Prevention and Tobacco Control Act (FSPTC Act), adds to FDA's duty to protect the public health. In addition to its new responsibilities for tobacco products, FDA is responsible for making sure that foods and cosmetics are safe; human and veterinary drugs, biological products, and medical devices are safe and effective; and products that emit radiation are safe.

Tobacco use is the leading cause of early deaths in America. Over eight million people in the United States have smoking-related chronic illnesses and over 400,000 people in the United States die each year from cigarette smoking and exposure to tobacco smoke.

The Federal Food and Drugs Act of 1906 provided FDA (known then as the Bureau of Chemistry of the U.S. Dept. of Agriculture) the authority to prevent the interstate commerce of adulterated or misbranded foods and drugs.

In 1938, following the tragic deaths of over 100 adults and children who had taken an untested medicine, The Federal Food, Drug, and Cosmetic Act of 1938 was enacted, giving FDA the authority, among other things, to require that drugs be proven safe before they could be marketed, establish "tolerances" (maximum allowable levels) for certain harmful substances, and to set standards of identity and quality.Until now tobacco products, unlike other consumer products, have for the most part been exempt from federal regulations that are meant to protect consumers. For example, prior to passing the FSPTC Act, under federal law tobacco products did not have to reveal ingredients in tobacco products or be tested before they could be marketed to consumers.

What will the Family Smoking Prevention and Tobacco Control Act do?The FSTPC Act gives FDA the authority to regulate tobacco products. The authority given FDA includes how tobacco products are manufactured, marketed, and distributed. Some of the key elements of the FSPTC Act are:

Requiring companies who manufacture or import tobacco products to provide FDA with a listing of the amounts of all ingredients in the tobacco products they produce.

Giving FDA the authority to require companies to provide information about the amount of nicotine in their products to FDA and the public.

Giving FDA the authority, when appropriate for protecting public health, to adopt standards for nicotine yields and for the reduction or elimination of other harmful substances that may be present in tobacco products.

Requiring that FDA must review an application and determine the product meets certain standards before tobacco products can be marketed and promoted as being "light", "mild" or "low". Premarket review by FDA is also required for tobacco products that were not commercially marketed as of February 15, 2007, or were modified after that date.

Requiring the warnings on tobacco products to cover 50 percent of the front and back panels of the package and that text be large and legible.

Establishing a Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to FDA, such as on safety, dependence, or other health issues related to tobacco products.